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tramadol hydrochloride tablet film coated

1 INDICATIONS & USAGE Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.1 )], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: • Have not been tolerated or are not expected to be tolerated. • Have not provided adequate analgesia or are not expected to provide adequate analgesia. Tramadol hydrochloride tablets are an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate ( 1 ). Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses ( 5.1 ), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: • Have not been tolerated or are not expected to be tolerated. • Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

macleods pharmaceuticals limited


6 years ago OVAL WHITE ML 4 tramadol hydrochloride tablet film coated

OVAL WHITE ML 4

6 years ago OVAL WHITE ML 4 tramadol hydrochloride tablet film coated

ML 4 OVAL WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING Tramadol hydrochloride tablets USP, 50 mg are white to off-white, capsule shaped, biconvex, film-coated tablets debossed with “ML 4” on one side and plain on other side. Bottle of 100 tablets: NDC 33342-201-11 Bottle of 500 tablets: NDC 33342-201-15 Bottle of 1000 tablets: NDC 33342-201-44 Dispense in a tight container. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. ‎"Store tramadol hydrochloride tablets securely and dispose of properly [see Patient Counseling Information ( 17 )].


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